Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
This study has been completed.
Sponsor:
Purdue Pharma LP
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01688947
First received: September 17, 2012
Last updated: May 9, 2014
Last verified: May 2014
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Purpose
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Postherpetic Neuralgia Pain |
Drug: V116517 50-mg tablets Drug: V116517 30-mg tablets Drug: Pregabalin capsules Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN) |
Resource links provided by NLM:
Further study details as provided by Purdue Pharma LP:
Primary Outcome Measures:
- "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Patient Global Impression of Change (PGIC) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Supplemental Analgesic Medication Use [ Time Frame: Over 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 105 |
| Study Start Date: | September 2012 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: V116517 - 50 mg
V116517 50-mg tablets
|
Drug: V116517 50-mg tablets
Taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
|
|
Experimental: V116517 - 30 mg
V116517 30-mg tablets
|
Drug: V116517 30-mg tablets
Taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
|
|
Active Comparator: Pregabalin
Pregabalin capsules
|
Drug: Pregabalin capsules
1-2 capsules taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
|
Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition.
- Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.
Key Exclusion Criteria:
- Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
- Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
- Subjects with a recent history of seizure within the past 5 years.
- Subjects who use opioids more than 4 days per week.
- Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
- Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
-
PHN-pain-condition-specific exclusions:
- Subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps.
-
Active-comparator-related exclusions:
- Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.
Other protocol specific inclusion/exclusion criteria may apply.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01688947
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01688947
Show 28 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
More Information
No publications provided
| Responsible Party: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT01688947 History of Changes |
| Other Study ID Numbers: | VND2002 |
| Study First Received: | September 17, 2012 |
| Last Updated: | May 9, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
Pain Neuralgia, Postherpetic |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Peripheral Nervous System Diseases Signs and Symptoms Pregabalin Analgesics Anticonvulsants |
Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015